What is MDSAP?
The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing Organizations authorized by the participating Regulatory Authorities to audit under MDSAP requirements.
How RQS can help you with MDSAP
- RQS can help you understand the MDSAP and how it will affect you.
- RQS can help you understand the nonconformity grading system used with MDSAP.
- Assist you with gap assessments and analysis to understand the impact & challenges facing you.
- Help you schedule and plan updates for your QMS to make MDSAP work for you.
- Help you to complete the transition sooner rather than later.
Who are the Regulatory Authorities Participating?
The regulatory authorities currently participating include the United States, Canada, Brazil, and Australia. Japan is acting as official observers and active participants in the program’s Regulatory Authority Council and subject matter expert groups.
How to Prepare for MDSAP
a. Put your internal audit and/or record requirements under scrutiny. Compare your existing processes against the forthcoming requirements and begin creating your plan to address the gaps, if there are any.
b. Get management involved in reviewing audit reports, and the records themselves.
c. Increase the sample size and frequency of records audits
d. Get management to sample records and give them in-person access to these sampled records
e. Challenge your ability to produce requested records in a timely manner – this should be less than an hour if possible.
Understand the new regulations have the potential to streamline quality management processes and bring new efficiencies to the organization –– but it comes at a price. A new level of requirements are beginning to align with a greater endeavor that quality enterprise-wide, rather than department-level.
If you prepare now for the new ISO requirements and MDSAP, audits not only position themselves for compliance in the new regulatory environment, but also position themselves for success in meeting other challenges of the future affecting the organization.
What is the Structure of MDSAP?
The program basically utilizes ISO 13485:2003 as a framework, in along with good manufacturing practice (GMP) requirements of the various regulatory authorities. Auditors will follow a structured and logical process approach, with links to other processes; this is all clearly explained in the medical device application profile (MDAP) audit model and the MDSAP Companion Document.
With the introduction of ISO 13485:2016, MDSAP will likely align to the new ISO 13485 standard. The model includes seven processes:
- Primary processes 1) Management, 2) Measurement, Analysis, and Improvement, 3) Design and Development, and 4) Production and Service Controls
- Supporting processes 5) Purchasing, 6) Device Marketing Authorization and Facility Registration, and 7) Medical Device Events and Advisory Notices Reporting